Efficacy and Tolerability of Almotriptan in Controlled Clinical Trials

Abstract

Seven triptans are now available for the acute treatment of migraine. While all of these agents have been shown to be safe and more or less well tolerated, they differ in ways that are clinically relevant to individual patients. Almotriptan has been investigated in approximately 3,500 patients enrolled in short-term clinical trials and 1,500 patients enrolled in long-term open-label trials. In a meta-analysis of placebo-controlled almotriptan trials (n = 2,294), treatment with almotriptan 12.5 mg results in a 2-hour pain-relief rate of 63.7% and a 2-hour pain-free rate of 36.4%. Almotriptan is associated with a rapid onset of action, with 30-min pain-relief and pain-free rates significantly better than placebo (p < 0.05). Direct comparator studies show the efficacy of almotriptan 12.5 mg to be comparable to that of sumatriptan but almotriptan is associated with superior tolerability. Trials assessing the efficacy of almotriptan over multiple attacks show that this agent is associated with a consistent and persistent response, not differing from the first to the last attack, an important property for a medication used to treat a chronic condition such as migraine. Early intervention with almotriptan enhances the activity of this agent. Treatment of mild pain with almotriptan has resulted in 2-hour pain-free rates of 84 and 77% and a sustained pain-free rate of 67%. Early treatment (within 1 h) of moderate to severe headaches with almotriptan also improves outcomes. In conclusion, clinical trials and post hoc analyses of such trials have shown almotriptan to be effective and well tolerated for the acute treatment of migraine. Its placebo-like tolerability makes it a good choice for early intervention, a strategy associated with better patient outcomes.

Long‐Term, Open‐Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

“…Treatment with oral almotriptan 12.5 mg was well tolerated by this adolescent patient population, with the most common treatment‐related AEs being nausea and somnolence. This is consistent with the overall experience of almotriptan treatment in adults, which has been associated with a tolerability profile comparable to that of placebo 28 . No unexpected safety concerns for almotriptan treatment were revealed in this population of adolescents with migraine.…”

“…This is consistent with the overall experience of almotriptan treatment in adults, which has been associated with a tolerability profile comparable to that of placebo. 28 No unexpected safety concerns for almotriptan treatment were revealed in this population of adolescents with migraine.…”

Evaluation of Efficacy, Tolerability, and Treatment Satisfaction with Almotriptan in 3 Consecutive Migraine Attacks

“…While one might argue that the improved efficacy rates seen here are due solely to early treatment of mild headache [13], it must be noted that baseline pain intensity was mild in only 15% of patients; it was moderate in 50% and severe in 35%.…”

Crossover, double‐blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy

“…The accumulated body of clinical data on almotriptan indicates that it is a very well‐tolerated triptan with a placebo‐like tolerability profile [30]. A meta‐analysis of 53 trials of oral triptans showed that only almotriptan 12.5 mg and naratriptan 2.5 mg had a lower rate of all AEs compared with sumatriptan 100 mg and that almotriptan 12.5 mg was the only triptan with a significantly lower rate of CNS AEs and chest AEs compared with sumatriptan 100 mg [16].…”